Plenity™

GUDID 00860517002627

Super-absorbent hydrogel to aid in weight management.

GELESIS, INC.

Ingested gastric satiety device

• Primary Device ID: 00860517002627
• NIH Device Record Key: a8dd2178-e97c-4a24-93d1-ef521a1efcb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Plenity™
• Version Model Number: MC0451
• Company DUNS: 010729307
• Company Name: GELESIS, INC.
• Device Count: 7
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-844-753-6489
• Email: info@gelesis.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860517002603 [Primary]
GS1	00860517002627 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN180060

FDA Product Code

• QFQ: Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-17
• Device Publish Date: 2020-03-09

On-Brand Devices [Plenity™ ]

• 00860517002627: Super-absorbent hydrogel to aid in weight management.
• 00860517002634: Super-absorbent hydrogel to aid in weight management.